Gross profit margin slipped to 20.8% during the quarter under review from 21.6% in the year-ago previous quarter owing to higher expenditure, which grew by 19%
This is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported carcinogenic impurity in the drug at low levels
Observations are related to procedural improvements, not data integrity, says the company
The management believes that these observations are related to procedural improvements and none of the observations are related to data integrity.
The exchange had sought a clarification from the company regarding declining share prices on the back of USFDA observations
The Nifty Pharma index fell 3.35 per cent during the day.
The Telangana unit in question is an important one contributing about a fifth to US revenues
The order said that the penalty amount will be paid within 45 days of receipt of this order
The company failed to disclose the price sensitive information regarding the Licensing and Supply Agreements to the stock exchange.
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The completion of Sandoz acquisition and new product launches are triggers
Revenue from operations rose 28.1% year-on-year to Rs 5,444.6 crore during the quarter under review
Aurobindo had reported Rs 19,563.6 crore in revenues in FY19 with an year-on-year growth of 18.5 per cent
Firm may have a tough task ahead improving manufacturing practices across the board through remediation running into months and years
Aurobindo Pharma share price fell as much as 7.7 per cent to Rs 578.75
The company's stock took a beating after the USFDA pointed out data integrity lapses at the firm's formulations facility in Telangana's Bachupally
The company said it was confident that the contamination in valsartan will not spread to other products
None of the observations are repetitive and are more procedural in nature, Aurobindo Pharma said
Product launches, acquisitions are expected to drive US, EU prospects
According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory and/or administrative sanctions by FDA are indicated" during inspections